Sun Pharmaceuticals Industries, Inc. SEZ Unit-l, Plot A-41, Industrial Area, Phase VIII-A
Form 483 issued July 16, 2016 · S.A.S, India
- Inspection
- Nov 7 – Nov 16, 2016
- Investigators
- Daniel J. Roberts· Steven D. Kehoe
- Observations
- 2
- Pages
- 4
In short: On July 16, 2016, FDA issued a Form 483 with 2 observations to Sun Pharmaceuticals Industries, Inc. SEZ Unit-l, Plot A-41, Industrial Area, Phase VIII-A in S.A.S, India after an inspection that ran Nov 7 – Nov 16, 2016. The investigators were Daniel J. Roberts and Steven D. Kehoe. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 1 system, led by quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Observation 2: scanned text, readable in the full document.
This inspection in context
Daniel J. Roberts
14 documents · 2011–2017
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmSun Pharmaceuticals Industries, Inc. SEZ Unit-l, Plot A-41, Industrial Area, Phase VIII-A history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sun Pharmaceuticals Industries, Inc. SEZ Unit-l, Plot A-41, Industrial Area, Phase VIII-A?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Sun Pharmaceuticals Industries, Inc. SEZ Unit-l, Plot A-41, Industrial Area, Phase VIII-A?
Daniel J. Roberts and Steven D. Kehoe are named on this Form 483, for the inspection of Nov 7 – Nov 16, 2016. Each investigator has a profile showing what they cite most.
When was Sun Pharmaceuticals Industries, Inc. SEZ Unit-l, Plot A-41, Industrial Area, Phase VIII-A inspected by FDA?
The inspection ran Nov 7 – Nov 16, 2016, and the Form 483 is dated July 16, 2016.
How do I get the full Form 483 for Sun Pharmaceuticals Industries, Inc. SEZ Unit-l, Plot A-41, Industrial Area, Phase VIII-A?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.